Renal ImpairmentNCT04273230
Kidney Affection in Non Alcaholic Fatty Liver Diseases
An observational study of Renal Impairment, run by Assiut University at 2 sites in Egypt.
Trial summary
Early detection of renal affection in patients with non alcaholic fatty liver diseases using microalbuminuria. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Impairment
- What is being tested?
- Microalbuminuria detection
- How many people
- 114 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Mar 2020to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: All pateints with fatty liver diseases diagnosed by ultrasonography and lab investigation
Who may be able to join
- All patients with fatty liver disease diagnosed by abdominal ultrasonogarphy .
- All patients with fatty liver disease diagnosed by lab investigations.
Who cannot join
- Diabetic patients
- Hypertensive patients
- patients with chronic kidney disesase
- patient with systemic diseases or chronic liver diseases affecting kidneys.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Early Detection of Kidney Affection in Non Alcaholic Fatty Liver Diseases(NAFLD)
Early detection of renal affection in patients with non alcaholic fatty liver diseases using microalbuminuria.
Read the detailed description
With the increasing prevalence of obesity, diabetes mellitus and the metabolic syndrome in the general population, non-alcoholic fatty liver disease (NAFLD) has become the most common cause of chronic liver disease. NAFLD refers to a wide spectrum of liver damage, ranging from simple steatosis to non-alcoholic steatohepatitis, advanced fibrosis and cirrhosis as well hepatocellular carcinoma.
Several large cross-sectional population and hospital-based studies involving both diabetic patients and patients without diabetes have consistently shown that the prevalence of CKD is increased in people with NAFLD . NAFLD and CKD share some common features, including visceral obesity,T2DM, hypertension and metabolic syndrome . The possible link between NAFLD and CKD has recently attracted considerable scientific interest. Establishing a link between liver and kidney injury would enhance the earlier identification of kidney disease and allow for the selection of treatments targeting both liver and kidney disease with potentially relevant preventive and therapeutic implications . The ultimate goal of identifying patients with established but also with early kidney damage is to prevent disease progression and minimize complications, to promote quality of life and improve survival .
Many recent studies, including the meta-analysis from Musso et al. suggest that individuals with NAFLD should be screened for CKD by estimation of GFR and urinalysis even in the absence of classical risk factors for CKD, particularly if NASH and/or advanced fibrosis are suspected . Early recognition of impaired kidney function in patients with NAFLD, may also allow drug dosage adjustment, thus preventing drug accumulation especially in those being treated for obesity associated co-morbidities.
Chronic kidney disease (CKD) is defined by the presence of reduced glomerular filtration rate (GFR <60 mL/min/1.73 m2)and/or evidence of kidney damage (usually indicated by albuminuria or proteinuria) for 3 or more months . On the other hand kidney failure is defined as a GFR of less than 15 mL/min per 1.73 m2,or the need for treatment with dialysis or transplantation . In clinical practice the most common tests for CKD diagnosis include eGFR estimated from the serum creatinine concentration and albuminuria from the urinary albumin-to-creatinine ratio (ACR). The importance of eGFR and albuminuria as diagnostic tools becomes obvious by their use in classification of CKD patients in stages .On the basis of GFR the disease is classified into five stages:more than 90 mL/min per 1.73 m2(stage 1), 60-89 mL/min per1.73 m2(stage 2), 30-59 mL/min per 1.73 m2(stage 3), more specific 45-59 mL/min per 1.73 m2(stage 3a) and 30-44 mL/min per1.73 m2(stage 3b), 15-29 mL/min per 1.73 m2(stage 4) and less than 15 mL/min per 1.73 m2(stage 5) .
Albuminuria as a marker of kidney damage is characterized by increased glomerular permeability and urine ACR > 30 mg/g. The normal urinary ACR in young adults is <10 mg/g. Urine ACR categories 10-29, 30-300and >300 mg are high normal, high, and very high, respectively.Urine ACR >2000 mg/g is accompanied by signs and symptoms of nephrotic syndrome (low serum albumin, edema, and high serum cholesterol)
- Conditions
- Renal Impairment
- Being tested
- Microalbuminuria detection
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microalbuminuria detectionOther
Detection of microalbumin in urine
What is being measured
The primary outcome is the main question the study is designed to answer.
Early detection of kidney affection in non alcaholic fatty liver diseases
Finding patients with non alcaholic fatty liver diseases who develop renal impairment
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start1 Mar 2020
- Primary completion1 Mar 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Atta Saad Girgis, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273230
- Sponsor's protocol ID
- Kidney affection in NAFLD
- Status last verified
- Feb 2020
- First submitted
- 14 Feb 2020
- Last updated
- 23 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arase Y, Suzuki F, Kobayashi M, Suzuki Y, Kawamura Y, Matsumoto N, Akuta N, Kobayashi M, Sezaki H, Saito S, Hosaka T, Ikeda K, Kumada H, Ohmoto Y, Amakawa K, Tsuji H, Hsieh SD, Kato K, Tanabe M, Ogawa K, Hara S, Kobayashi T. The development of chronic kidney disease in Japanese patients with non-alcoholic fatty liver disease. Intern Med. 2011;50(10):1081-7. doi: 10.2169/internalmedicine.50.5043. Epub 2011 May 1.
PubMed 21576832Kiapidou S, Liava C, Kalogirou M, Akriviadis E, Sinakos E. Chronic kidney disease in patients with non-alcoholic fatty liver disease: What the Hepatologist should know? Ann Hepatol. 2020 Mar-Apr;19(2):134-144. doi: 10.1016/j.aohep.2019.07.013. Epub 2019 Sep 23.
PubMed 31606352Park H, Dawwas GK, Liu X, Nguyen MH. Nonalcoholic fatty liver disease increases risk of incident advanced chronic kidney disease: a propensity-matched cohort study. J Intern Med. 2019 Dec;286(6):711-722. doi: 10.1111/joim.12964. Epub 2019 Aug 23.
PubMed 31359543
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Kidney Affection in Non Alcaholic Fatty Liver Diseases(NAFLD)
- ClinicalTrials.gov ID
- NCT04273230
- Acronym / sponsor ID
- Kidney affection in NAFLD
- Conditions
- Renal Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early detection of renal affection in patients with non alcaholic fatty liver diseases using microalbuminuria.
Detailed description
With the increasing prevalence of obesity, diabetes mellitus and the metabolic syndrome in the general population, non-alcoholic fatty liver disease (NAFLD) has become the most common cause of chronic liver disease. NAFLD refers to a wide spectrum of liver damage, ranging from simple steatosis to non-alcoholic steatohepatitis, advanced fibrosis and cirrhosis as well hepatocellular carcinoma.
Several large cross-sectional population and hospital-based studies involving both diabetic patients and patients without diabetes have consistently shown that the prevalence of CKD is increased in people with NAFLD . NAFLD and CKD share some common features, including visceral obesity,T2DM, hypertension and metabolic syndrome . The possible link between NAFLD and CKD has recently attracted considerable scientific interest. Establishing a link between liver and kidney injury would enhance the earlier identification of kidney disease and allow for the selection of treatments targeting both liver and kidney disease with potentially relevant preventive and therapeutic implications . The ultimate goal of identifying patients with established but also with early kidney damage is to prevent disease progression and minimize complications, to promote quality of life and improve survival .
Many recent studies, including the meta-analysis from Musso et al. suggest that individuals with NAFLD should be screened for CKD by estimation of GFR and urinalysis even in the absence of classical risk factors for CKD, particularly if NASH and/or advanced fibrosis are suspected . Early recognition of impaired kidney function in patients with NAFLD, may also allow drug dosage adjustment, thus preventing drug accumulation especially in those being treated for obesity associated co-morbidities.
Chronic kidney disease (CKD) is defined by the presence of reduced glomerular filtration rate (GFR <60 mL/min/1.73 m2)and/or evidence of kidney damage (usually indicated by albuminuria or proteinuria) for 3 or more months . On the other hand kidney failure is defined as a GFR of less than 15 mL/min per 1.73 m2,or the need for treatment with dialysis or transplantation . In clinical practice the most common tests for CKD diagnosis include eGFR estimated from the serum creatinine concentration and albuminuria from the urinary albumin-to-creatinine ratio (ACR). The importance of eGFR and albuminuria as diagnostic tools becomes obvious by their use in classification of CKD patients in stages .On the basis of GFR the disease is classified into five stages:more than 90 mL/min per 1.73 m2(stage 1), 60-89 mL/min per1.73 m2(stage 2), 30-59 mL/min per 1.73 m2(stage 3), more specific 45-59 mL/min per 1.73 m2(stage 3a) and 30-44 mL/min per1.73 m2(stage 3b), 15-29 mL/min per 1.73 m2(stage 4) and less than 15 mL/min per 1.73 m2(stage 5) .
Albuminuria as a marker of kidney damage is characterized by increased glomerular permeability and urine ACR > 30 mg/g. The normal urinary ACR in young adults is <10 mg/g. Urine ACR categories 10-29, 30-300and >300 mg are high normal, high, and very high, respectively.Urine ACR >2000 mg/g is accompanied by signs and symptoms of nephrotic syndrome (low serum albumin, edema, and high serum cholesterol)
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All pateints with fatty liver diseases diagnosed by ultrasonography and lab investigation
Key inclusion criteria (2 listed)
- All patients with fatty liver disease diagnosed by abdominal ultrasonogarphy .
- All patients with fatty liver disease diagnosed by lab investigations.
Key exclusion criteria (4 listed)
- Diabetic patients
- Hypertensive patients
- patients with chronic kidney disesase
- patient with systemic diseases or chronic liver diseases affecting kidneys.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microalbuminuria detectionDetection of microalbumin in urine | Other | – |
Primary outcome
Early detection of kidney affection in non alcaholic fatty liver diseases
Time frame: Baseline
Finding patients with non alcaholic fatty liver diseases who develop renal impairment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Background: PubMed 21576832Arase Y, Suzuki F, Kobayashi M, Suzuki Y, Kawamura Y, Matsumoto N, Akuta N, Kobayashi M, Sezaki H, Saito S, Hosaka T, Ikeda K, Kumada H, Ohmoto Y, Amakawa K, Tsuji H, Hsieh SD, Kato K, Tanabe M, Ogawa K, Hara S, Kobayashi T. The development of chronic kidney disease in Japanese patients with non-alcoholic fatty liver disease. Intern Med. 2011;50(10):1081-7. doi: 10.2169/internalmedicine.50.5043. Epub 2011 May 1.
- Background: PubMed 31606352Kiapidou S, Liava C, Kalogirou M, Akriviadis E, Sinakos E. Chronic kidney disease in patients with non-alcoholic fatty liver disease: What the Hepatologist should know? Ann Hepatol. 2020 Mar-Apr;19(2):134-144. doi: 10.1016/j.aohep.2019.07.013. Epub 2019 Sep 23.
- Background: PubMed 31359543Park H, Dawwas GK, Liu X, Nguyen MH. Nonalcoholic fatty liver disease increases risk of incident advanced chronic kidney disease: a propensity-matched cohort study. J Intern Med. 2019 Dec;286(6):711-722. doi: 10.1111/joim.12964. Epub 2019 Aug 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Impairment, run by Assiut University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early detection of kidney affection in non alcaholic fatty liver diseases (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04273230, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.